Health TrialsbyHealthPanel

A Randomized Study of a Short Duration Therapy for Candidemia

ConditionCANDIDEMIA
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

Scientific justification Candidemia is a major public health problem. In France, the 30-day mortality of candidemia varies from 30% to 50% depending on the need for intensive care and it has not decreased in 30 years.

The duration of treatment for candidemia was set at a minimum of 14 days after the last positive blood culture following the Rex trial (1) comparing the efficacy of fluconazole vs amphotericin B where the minimum duration of treatment was imposed. The risk of a too short treatment is the absence of control of the candidemia with secondary dissemination, in particular cardiac and ophthalmic.

A retrospective study looking at the risk of ophthalmologic complications after candidemia found among the 21/78 treated for less than 14 days, only one case of late endophthalmitis in a patient who had only been treated for 48 hours. In addition, the prolonged duration of antifungals exposes the risk of selection of more resistant strains with a modification of the flora, with the possibility of acquiring resistance as early as 8 days of treatment with caspofungin, and has a greater liver toxicity.

There is no prospective study on the direct impact of antifungal agents (type of antifungal agent and duration) on the mycobiota.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults (Age ≥ 18 years old)

With an uncomplicated candidemia defined by the absence of secondary sites requiring prolonged treatment: endocarditis, ophthalmologic involvement, thrombosed catheter, arthritis, meningitis, candida abscess that cannot be drained, pyelonephritis.

Without expected aplasia duration greater than 7 days

Being apyretic and having a 1st negative blood culture after diagnosis

Disqualifiers

Presence of an indwelling vascular catheter or device that cannot be removed or an abscess that cannot be drained and is likely to be the source of candidemia or the presence of secondary sites of candidemia requiring prolonged treatment

Patients with more than 7 days of aplasia

Candida strain resistant to the antifungal used

Pregnancy, breastfeeding

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard of Care (SOC)

    Drug

    14 days of antifungal therapy after the 1st negative blood culture

  • Shortened duration of antifungal therapy

    Drug

    7 days of antifungal therapy after the 1st negative blood culture

Treatment groups

362 Participants
are divided into 2 treatment groups
Group A: 14 days of antifungal treatmentActive comparator 1 intervention
Group B: 7 days of antifungal treatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

All-cause mortality (ACM)

at day 28 after the 1st negative blood culture under antifungal treatment for all patients included with an uncomplicated candidemia

Time frame
At day 28

Secondary outcomes

1

Proportion of patients with secondary localizations

Time frame
At day 28
2

Cumulative incidence of death related to fungal infection

at Day 28 after the 1st negative blood culture under antifungal treatment

Time frame
At day 28
3

Aspartate Amino-transferase level

Time frame
At day 14
4

Aspartate Amino-transferase level

Time frame
At day 28

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: